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Sr. Director, Global Regulatory Affairs

Employer
Santen, Inc.
Location
Emeryville, CA, United States
Start date
Dec 3, 2020

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Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay
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Job Details

Role

The Senior Director of Global Regulatory Affairs is responsible for the planning, integrating, and developing Santen Inc.’s regulatory strategy and managing regulatory activities, leading to rapid approval of Santen products and/or appropriate maintenance of marketed products. This is a hands-on leadership role and will provide strategic and operational leadership for the direction, planning, execution and conduct of regulatory objectives, projects and submissions. This position will lead a U.S. regulatory team of six; a two Sr. Regulatory Specialists, two Sr. Regulatory Affairs Specialists and a Regulatory Affairs Manager, and a Director, Regulatory Affairs.

Responsibilities

The Sr. Director will define, develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Specific responsibilities include:
  • Provide strategy for US and Canadian registration of Santen Products and occasionally the integration of US strategy into a global regulatory strategy on global projects.
  • Provides strategic and tactical advice to the team to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
  • Is a leader within Santen and external to Santen, contributing to cross-functional initiatives and influencing the field.
  • Provides leadership and development for six (6) direct reports.
  • Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
  • Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Sr. Director will lead all submission types.
  • Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings.
  • Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Santen affiliates in compliance with local regulations and to maintain compliance for products.
  • Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
  • Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
  • Responsible for demonstrating Santen leadership behaviors.

Qualifications

The successful candidate must be a skilled relationship developer, employ an entrepreneurial spirit, and passionately embody the Santen mission.
  • Minimum 10+ years successful management experience.
  • 12+ years of experience in regulatory affairs with specific focus on FDA and Health Canada.
  • 15+ years of experience in the pharmaceutical or biotech industry (ophthalmic experience preferred).
  • Experience developing staff/people.
  • Effective negotiation and decision making skills.
  • Direct experience negotiating with the FDA.
  • Experience in pre-approval inspections.
  • Experience in registration of sterile products.
  • Experience leading project teams.
  • Experience managing regulatory professionals.
  • Thorough knowledge of GMPs, GLPs, GCPs, ICH guidelines, and US regulatory guidelines.
  • Working knowledge of EU and Japanese regulations.
  • Proficient at intermediate level with Microsoft Office suite of software.
  • Excellent written, verbal and presentation skills.
  • Demonstrated ability to collaborate cross-functionally.
  • Proven track record of effective planning and organizational skills.
  • Ability to originate and complete projects with little to no oversight.
  • Ability to interact successfully with multiple diverse cultures.

Education
  • Bachelor’s in a scientific field required; Advanced Degree preferred.

Goals and Objectives

Within the first 12-24 months, the Sr. Director will have been expected to:
  • Develop and file NDAs.
  • Build relationship with the industry experts.
  • Participate in speaking engagements, panel discussions, publications, etc.
  • Be looked upon within Santen as a can-do, hands-on leader, who has integrated well into Santen entrepreneurial culture.

Company

Santen is a global pharmaceutical and medical device company focused solely on ophthalmology. We’re committed to serving serious unmet needs by developing innovative solutions that protect vision and, in turn, preserve quality of life for people around the world.

Santen USA, located in Emeryville, CA, is an important part of our ophthalmic research, development, and commercialization efforts worldwide and the home of our regional business teams. By leveraging our deep industry knowledge and a network of external partners, we aim to deliver game-changing therapies and make hope a reality for people facing vision impairment and loss.

Our deep roots start in Japan, Santen’s worldwide headquarters, where the company began in 1890. Since then, Santen has become an established leader in the Asian and European prescription ophthalmology marketplaces and continues to expand across global markets, including the United States. Today, Santen employs more than 4,000 people worldwide and sells specialty ophthalmic products in more than 60 countries.

With a clear focus on vision, we aim to deliver the highest quality products, to act with integrity, to earn the trust of our partners and customers, and to deliver sight-saving innovations to physicians and patients who are waiting for them.
 

 

Company info
Website
Location
6401 Hollis Street
Emeryville, CA 94608
 United States
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